Comparison of the Transcutaneous Tibial Nerve Stimulation and Drug Treatment' Effects in Women With Overactive Bladder

NCT06024005 | Completed

• 1 other identifier: TTNS for OAB
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Overactive bladder (OAB) syndrome is a symptom complex characterized by sudden urgency, frequent urination, nocturia, and urge incontinence without any identifiable organic cause, significantly impacting the quality of life. One of the most prominent symptoms is the urgency to urinate accompanied by a sudden sensation of bladder fullness. There are various treatment options available for managing OAB, including conservative therapy, pharmacotherapy, and surgical management. High-level evidence supports solifenacin as the standard medical treatment for OAB, offering advantages such as not being affected by food intake, efficacy regardless of gender, and high bioavailability. However, it is known to cause discontinuation of treatment in many cases due to the occurrence of side effects. Posterior tibial nerve stimulation (PTNS) is a neuromodulation technique that has been internationally recognized and proven effective in the treatment of OAB, providing several advantages. It can be applied through two methods: percutaneous (PTNS) and transcutaneous (TTNS). PTNS is an invasive method that requires specialized equipment and a trained healthcare professional, which limits its routine use due to treatment costs. In the literature, it is stated that in the treatment of OAB, alone or combined PTNS applications are superior to drug monotherapies, but there are limited studies on this subject. Therefore, the study aim was to compare the efficacy, side effects and quality of life of solifenacin and TTNS.

Conditions

Overactive Bladder; Overactive Bladder Syndrome

Keywords

Overactive Bladder; Transcutaneous Electric Nerve Stimulation; Neuromodulation; Urge Urinary Incontinence; Quality of Life

Outcome Measures

Primary Outcomes (2)

• Number of Total Daily Incontinence Episodes

  It was obtained using a three-day bladder diary. Objective. Meaningful for patients. Correlates with patients' daily activities. It may not be directly related to the severity of urine leakage. Subject to variability. Requires patient compliance. Day and night urine leakages were recorded separately by the patient for three days. The mean total score for a day was calculated.

  6 weeks

• Evaluation of Quality of Life

  The Incontinence Quality of Life Scale (I-QOL), consisting of 22 questions, was used to analyze the improvement in quality of life. It is a validated questionnaire. Higher scores indicate a better level of quality of life compared to lower scores. It is meaningful for patients. It is standardized. It takes into account the patient's daily activities. Subjective. Subject to variability. Not correlated with the severity of urine leakage.

  6 weeks

Secondary Outcomes (3)

• Symptom Assessment

  6 weeks

• Symptom Assessment

  6 weeks

• Symptom Assessment

  6 weeks

Study Arms (2)

Device Group

ACTIVE COMPARATOR

Transcutaneous device group with Urostim 2

Device: Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)

Drug Group

ACTIVE COMPARATOR

Drug Group with Kinzy 5 mg

Drug: Oral Solifenacin 5mg

Interventions

Oral Solifenacin 5mg DRUG

Oral solifenacin (Kinzy 5mg) use once a day for 6 weeks

Also known as: Kinzy 5mg

Drug Group

Transcutaneous Posterior Tibial Nerve Stimulation (TTNS) DEVICE

Application of TTNS twice a week for 6 weeks, with each session for 30 minutes

Also known as: Urostim 2

Device Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with a diagnosis of OAB and unresponsive to first-line treatment,
• Absence of genito-urinary system malformations that may cause pollacullaire,
• Volunteering to participate in the research,
• To be literate in Turkish

You may not qualify if:

• Having a urinary tract infection,
• Having pelvic organ prolapse greater than stage 2,
• To be diagnosed with stress type urinary incontinence,
• Having narrow-angle glaucoma, myasthenia gravis and severe gastro-intestinal diseases,
• Patients undergoing hemodialysis,
• Having severe liver or kidney failure,
• Pregnancy,
• Having a pacemaker
• Presence of epilepsy,
• The presence of built-in metal in the ankle
• Open ankle wound

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University, School of Medicine, Department of Obstetrics and Gynecology

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge

Interventions

Solifenacin Succinate

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urinary Incontinence; Urination Disorders

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Ahmet Ozgur OY Yeniel

  Ege University School of Medicine, Department of Obstetrics and Gynecology,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 2, 2023
• First Posted: September 5, 2023
• Study Start: April 18, 2023
• Primary Completion: May 24, 2023
• Study Completion: May 24, 2023
• Last Updated: September 5, 2023

Record last verified: 2023-09

Locations

TU (1)